Warning letters, 483s, Recalls, Import Alerts, Audit observations
Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies
In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI
USFDA announced it has awarded 10 new clinical trial studies through Orphan Products Grants Program
USFDA has eliminated the REMS for Lotronex (alosetron hydrochloride) and approved generics. Alosetron hydrochloride is
As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.
USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim
